The National Academies
07/25/2024 | Press release | Distributed by Public on 07/25/2024 09:03
FDA, USDA, and Congress Should Address Vulnerabilities in the Infant Formula Market to Mitigate Future Shortages, Says New Report
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FDA, USDA, and Congress Should Address Vulnerabilities in the Infant Formula Market to Mitigate Future Shortages, Says New Report
News Release| July 25, 2024
WASHINGTON - Congress, the Food and Drug Administration, and the U.S. Department of Agriculture should address vulnerabilities in the supply and regulation of infant formula, says a new report from the National Academies of Sciences, Engineering, and Medicine. The report analyzes the infant formula market before and during the 2022 infant formula shortage and the resulting response - and makes recommendations to minimize the impact of future infant formula shortages and improve the market's resiliency.
In late 2021 and early 2022, the FDA received information about four cases of infants falling ill or dying after consuming powdered infant formula that was produced by Abbott. FDA initiated an investigation at the facility and warned consumers not to use certain products manufactured there, and Abbott implemented a voluntary recall and paused production. The pause in production, which was prolonged by flooding in the area, led to a widespread shortage of infant formula, unprecedented in its scope and duration, affecting families across the U.S. at all income levels. The report notes the shortage was particularly harmful to low-income households.
Infant formula produced or sold in the U.S. is subject to a complex regulatory environment that involves multiple federal agencies, including FDA, USDA, the Centers for Disease Control and Prevention, and Centers for Medicare and Medicaid Services. All FDA-registered manufacturing facilities, whether domestic or foreign, are subject to FDA inspection. About half of the infant formula purchased each year in the U.S. is provided to participants of USDA's Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).
"Infant formula is a critical food, and future disruptions need to be anticipated and prepared for," said Barbara Schneeman, chair of the committee that wrote the report and emeritus professor, University of California, Davis. "Our report recommends steps that should be taken now to not only reduce the risk of future shortages but also to make sure that when a disruption does occur, no parent has to face the anxiety and stress of not being able to find formula for their infant."
Risk Management Planning
Understanding and managing risks, and implementing a risk management plan in the case of a shortage, are key elements of a preparedness strategy for government and infant formula companies. Among other recommendations, HHS and FDA should create a risk management plan for the entire sector, and FDA should develop standards for risk management planning among infant formula manufacturers, the report says.
Concentrated Production
The report says the concentration of infant formula production at a few facilities is a vulnerability. Disruptions at a single facility - which the report notes are likely - can create significant supply challenges. Congress should provide incentives to encourage infant formula manufacturers to modernize their plants and equipment, including implementing measures that would prevent the spread of contaminants from one part of the facility to another. These incentives should be contingent on having met FDA's expectations for risk management planning.
The committee concluded that the WIC program's competitive bidding process - which awards the supply of all infant formula to WIC vendors in a state to a single formula brand - is not the driver of industry concentration. Ending the competitive bidding process could drive up the cost of infant formula for WIC and impact wholesale and retail prices. The report recommends that USDA help protect consumers from the effects of a supply disruption by facilitating formula distribution to WIC vendors during a disruption, and require manufacturers with WIC contracts to plan for and take specific actions during a supply disruption.
Managing Impact on Consumers and Families
A lack of clear coordination between government and industry, inadequate government communication with the public, and the unique constraints faced by families who rely on WIC to obtain formula all adversely affected consumers during the 2022 shortage. In particular, many families struggled to identify an appropriate substitute for a formula they were already using when their supply ran low.
The FDA and CDC should work with infant nutrition experts and formula manufacturers to develop consistent guidance on how caregivers should substitute infant formula - based on ingredients - as well as guidance for caregivers on how to feed infants when no breast milk or formula is available, says the report.
The FDA is currently required to maintain a list of appropriate substitutes for specialized kinds of infant formula used to feed infants with metabolic issues or other health conditions, but not for standard infant formula or hypoallergenic formulas. The report recommends FDA create and maintain a public list of all infant formulas currently marketed in the U.S. and their ingredients.
The report also recommends the USDA develop a dashboard to track critical data on infant formula supply and shortages, and to update its requirements and expectations for crisis response. CMS, the largest provider of insurance for children, should issue a rule requiring hospitals that accept Medicaid to have a plan in place in case of a disruption in nutrition support for hospitalized infants.
Supporting Speedy Supply Recovery
Restoring infant formula production was slowed in 2022 by certain aspects of FDA's authority to oversee manufacturing, as well as regulatory requirements that inhibited importing infant formula from outside the U.S.
The report recommends Congress grant FDA the authority to remotely access records for critical foods to strengthen its oversight during a crisis. Congress should also require infant formula manufacturers to give sufficient advance notice to FDA when they decide to discontinue a formula that is likely to lead to a disruption prior to removing the product from the market, and establish a "trigger rule" to automatically suspend tariffs and quotas for imported infant formula and materials used in domestic formula production in the event of a meaningful market disruption.
The report says that forming a better understanding of potential barriers to importing infant formula produced outside the U.S. prior to a disruption would speed up needed action during a shortage. FDA should collect information on nutrient and labeling requirements used by other countries, and create a database to be updated every four years, facilitating its ability to use enforcement discretion in the case of a shortage.
"Government and industry actions were ultimately successful in mitigating the 2022 shortage," said Ravi Anupindi, the committee's vice chair and Colonel William G. and Ann C. Svetlich Professor of Operations Research and Management at the University of Michigan. "But many of their actions simply took too long to initiate. Making reforms now to prevent and mitigate the impact of a disruption and enable a rapid future response, should one occur, is an important next step."
The report also notes that families that were able to and chose breastfeeding were not as affected by the shortage, and support for breastfeeding remains essential for infant health.
Undertaken by the Committee on Challenges in Supply, Market Competition, and Regulation of Infant Formula in the United States, the study was sponsored by the U.S. Department of Health and Human Services.
The National Academies of Sciences, Engineering, and Medicine are private, nonprofit institutions that provide independent, objective analysis and advice to the nation to solve complex problems and inform public policy decisions related to science, engineering, and medicine. They operate under an 1863 congressional charter to the National Academy of Sciences, signed by President Lincoln.
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Featured Publication
2024
Challenges in Supply, Market Competition, and Regulation of Infant Formula in the United States
Infant formula is a primary or supplementary source of nutrition for many infants in the U.S. Consequently, disruptions to the supply of infant formula can have a severe impact on infants' health and well-being. In late 2021 and early 2022, a recall of specific infant formula products, followed by a pause in production, resulted in a widespread, national shortage. The incident demonstrated that additional risk management planning is needed to protect infants from the consequences of potential future supply chain disruptions.
In 2023, the U.S. Food and Drug Administration contracted with the National Academies to convene an expert committee to examine and report on challenges in supply, market competition, and regulation of infant formula. The resulting consensus study report explains policy and marketplace vulnerabilities that were exposed during the shortage, describes the extent to which actions taken by relevant stakeholders addressed these vulnerabilities, identifies remaining gaps in the system, and recommends actions to reduce the risk and lessen the effect of any future disruption to the infant formula supply chain.
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